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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00634205
Other study ID # ELCWP-01062
Secondary ID
Status Completed
Phase Phase 2
First received March 5, 2008
Last updated February 11, 2015
Start date July 2006
Est. completion date June 2010

Study information

Verified date February 2015
Source European Lung Cancer Working Party
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health ProductsFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the response rate to the combination of doxorubicin and valproate acid in patients with MM failing after at least one previous chemotherapy regimen including platinum derivatives .


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date June 2010
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histological diagnosis of malignant mesothelioma

- Unresectable or inoperable malignant mesothelioma failing after at least one prior chemotherapy regimen including platinum derivatives (cisplatin or carboplatin)

- At least one evaluable or measurable CT-lesion

- Availability for participating in the detailed follow-up of the protocol

- Signed informed consent

Exclusion Criteria:

- Patients who are candidates for surgery with curative intent

- Patient who were previously treated with anthracyclin derivatives

- Performance status < 60 on the Karnofsky scale

- A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix and cured malignant tumour (more than 5-year disease free interval)

- A history of prior HIV infection

- Polynuclear cells < 2,000/mm³

- Platelet cells < 100,000/mm³

- Abnormal coagulation tests (aPTT, PTT, prothrombin time) and/or decreased fibrinogen

- Serum bilirubin >1.5 mg/100 ml

- Transaminases more than twice the normal range

- Serum creatinine > 1.5 mg/100 ml

- Recent myocardial infarction (less than 3 months prior to date of diagnosis)

- Congestive cardiac failure (ejectional fraction of the left ventricle < 50%) or uncontrolled cardiac arrhythmia

- Uncontrolled infectious disease

- Active epilepsy needing a specific treatment

- Concomitant treatment with IMAO, carbamazepine, mefloquine, phenobarbital, primidone, phenytoïn, lamotrigine, zidovudine

- Pregnancy or refusal to use active contraception

- A known allergy to valproate acid and/or doxorubicin

- Serious medical or psychological factors which may prevent adherence to the treatment schedule

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Valproate plus doxorubicin
Valproate 20-30 mg/kg orally (in order to obtain serum concentration between 50-100 mcg/ml) Doxorubicin 60 mg/m² intravenously every 3 weeks

Locations

Country Name City State
Belgium Department of Pneumology CHR St joseph - Warquignies Boussu
Belgium Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet Brussels
Belgium Department of Pneumology Hôpital Ixelles-Molière Brussels
Belgium Department of Pneumology CHU Charleroi Charleroi
Belgium Department of Pneumology Hôpital Saint-Joseph Gilly
Belgium Hôpital Ambroise Paré Mons
Belgium CH Peltzer-La Tourelle Verviers
France Department of Pneumology CHRU Lille Lille

Sponsors (1)

Lead Sponsor Collaborator
European Lung Cancer Working Party

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Response rate Every 3 courses Yes
Secondary Survival Survival will be dated from the day of registration until death or last follow up No
Secondary Toxicity After each course of chemotherapy and at the end of treatment No
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